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NCT01534663 · ClinicalTrials.gov registry record · Phase 2
Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT01534663 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 31 participants.
The verdict
NCT01534663, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation of fish oil and glutamine with placebo in patients with stable heart failure. 30 patients with heart failure will be randomized to either receiving 6.5 g fish oil/d and 8 g glutamine/d (n=15) or placebo (n=15) for 90 days. The primary outcome in this study is the change in muscle functional capacity measured as changes in maximum muscle strength and fatigability, peak VO2 and exercise time after supplementation. A secondary outcome is the measurement of systemic and local markers of inflammation.
Interventions
- DRUG Placebo
- DRUG Glutamine and Fish Oil Supplementation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01534663
The ClinicalTrials.gov registry entry for NCT01534663 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01534663 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01534663 about?
NCT01534663 is a clinical study titled "Supplementation of Glutamine and Fish Oil Versus Placebo in Patients With Heart Failure". The aim of this study is to determine whether supplementation of glutamine and fish oil can improve peripheral skeletal muscle function and metabolism in patients with heart failure. The investigators propose a randomized, double-blind, placebo controlled study comparing the combined supplementation...
What is the current status of trial NCT01534663?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2011-11. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01534663?
The interventions under investigation include: Placebo (DRUG), Glutamine and Fish Oil Supplementation (DRUG).
Who is sponsoring clinical trial NCT01534663?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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